# FDA 483 - Unknown Company - April 20, 2011

Source: https://www.keypedia.com/records/483/unknown-company/2f5f3ebd-eada-4e6f-bf72-3719480a20b8

> FDA 483 for Unknown Company on April 20, 2011. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Inspection Date: 2011-04-20
- Product Type: Food
- Office Name: Kansas City District Office
- Summary: During a recent inspection, the U.S. Food and Drug Administration (FDA) issued a Form 483 observation to an inspected facility, highlighting significant deficiencies in its food safety monitoring program. The primary concern identified was the failure of qualified supervisory personnel to consistently review critical documents mandated by the facility's SE Prevention Plan. This lapse in oversight is crucial for ensuring the safety and quality of products, particularly those susceptible to Salmonella Enteritidis (SE) contamination, commonly associated with shell eggs. Specifically, the FDA noted that several key monitoring logs had not been reviewed since the implementation of the SE Prevention Plan. These unreviewed documents included the facility's 'Temperature Record Log,' which tracks crucial environmental conditions; rodent monitoring logs, vital for pest control effectiveness; 'FLY Status Report' logs, addressing insect management; and the 'Pesticide Usage Log.' The absence of supervisory review for these records indicates a potential breakdown in the facility's Hazard Analysis and Critical Control Point (HACCP) system or equivalent preventative controls. To address this, the facility is required to promptly implement corrective actions, ensuring that all mandated SE Prevention Plan documents are regularly reviewed by qualified personnel to maintain compliance with federal food safety regulations and their own established procedures.

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## Related Officers

- [Andrew Houpes](https://www.keypedia.com/people/andrew-houpes/0b6d7778-a03e-4cab-a8b6-551652cf8d6e)
- [Inurahigaton Bonald](https://www.keypedia.com/people/inurahigaton-bonald/a5573cfd-e983-4f8c-b4b2-551bd122544f)
- [Kathleen J. Klier](https://www.keypedia.com/people/kathleen-j-klier/d4b068ba-0318-4966-9cf2-476102feebd7)

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79